Epilepsy

• FDA approval · 2020-10-02
  FDA Approved: VIGABATRIN — Supplemental Application (Cipla USA, Inc.)

  FDA approved a supplemental application for Vigabatrin by Cipla USA, Inc., granting an additional approval under the ANDA for Vigabatrin, ty…

• FDA approval · 2020-09-30
  FDA Approved: KEPPRA — Supplemental Application (UCB, Inc.)

  The FDA approved a supplemental application for Keppra (levetiracetam) from UCB, Inc.

• FDA approval · 2020-09-30
  FDA Approved: KEPPRA XR — Supplemental Application (UCB, Inc.)

  FDA approved a supplemental application for KEPPRA XR (levetiracetam), the extended-release formulation, submitted by UCB, Inc.

• FDA approval · 2020-09-29
  FDA Approved: GABAPENTIN — Supplemental Application (ScieGen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Gabapentin from ScieGen Pharmaceuticals, Inc.

• FDA approval · 2020-09-28
  FDA Approved: PHENYTOIN SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for phenytoin sodium by Hikma Pharmaceuticals USA Inc., under the ANDA pathway.

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• FDA approval · 2020-09-18
  FDA Approved: LEVETIRACETAM — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for levetiracetam from Torrent Pharmaceuticals Limited, granting the requested modification under th…

• FDA approval · 2020-09-16
  FDA Approved: GABAPENTIN — Supplemental Application (ACI Healthcare USA, Inc.)

  FDA approved a supplemental application for gabapentin from ACI Healthcare USA, Inc., updating the regulatory status of the product.

• FDA approval · 2020-09-10
  FDA Approved: LEVETIRACETAM — Supplemental Application (Apotex Corp.)

  The FDA approved Apotex Corp.'s supplemental application for a generic version of levetiracetam, enabling its sale as a generic antiepilepti…

• FDA approval · 2020-09-08
  FDA Approved: GABAPENTIN — Supplemental Application (Exelan Pharmaceuticals, Inc.)

  FDA approved a supplemental application for gabapentin from Exelan Pharmaceuticals, Inc. under an ANDA.

• FDA approval · 2020-08-31
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal (lamotrigine) submitted by GlaxoSmithKline LLC.

• FDA approval · 2020-08-31
  FDA Approved: XCOPRI — Supplemental Application (SK Life Science, Inc.)

  The FDA approved a supplemental application for XCOPRI (cenobamate) submitted by SK Life Science, Inc., resulting in updated labeling.

• FDA approval · 2020-08-28
  FDA Approved: FOSPHENYTOIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for fosphenytoin sodium (Fosphenytoin) from Fresenius Kabi USA, LLC. The action confirms an approved…

• FDA approval · 2020-08-26
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Advagen Pharma Limited)

  FDA approved a supplemental application for oxcarbazepine from Advagen Pharma Limited.

• FDA approval · 2020-08-26
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for oxcarbazepine filed by Sun Pharmaceutical Industries, Inc. (ANDA077794).

• FDA approval · 2020-08-25
  FDA Approved: OXCARBAZEPINE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  The FDA approved a supplemental application for oxcarbazepine from Glenmark Pharmaceuticals Inc., USA. This action represents a regulatory u…

• FDA approval · 2020-08-21
  FDA Approved: GABAPENTIN — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for gabapentin from Amneal Pharmaceuticals LLC.

• FDA approval · 2020-08-19
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal (lamotrigine) from GlaxoSmithKline.

• FDA approval · 2020-08-19
  FDA Approved: LAMICTAL — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal (lamotrigine) filed by GlaxoSmithKline LLC.

• FDA approval · 2020-08-19
  FDA Approved: LAMICTAL ODT — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Lamictal ODT (lamotrigine) from GlaxoSmithKline LLC, adding or updating the orally disintegratin…

• FDA approval · 2020-08-17
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for diazepam from Hikma Pharmaceuticals USA Inc., updating the approved product under the existi…

• FDA approval · 2020-08-17
  FDA Approved: GABAPENTIN — Original Application (Zhejiang Yongtai Pharmaceutical Co., Ltd)

  FDA approved the original application for gabapentin from Zhejiang Yongtai Pharmaceutical Co., Ltd., authorizing a generic gabapentin produc…

• FDA approval · 2020-08-07
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for DILANTIN Extended Phenytoin Sodium filed by Viatris Specialty LLC.

• FDA approval · 2020-07-28
  FDA Approved: GABAPENTIN — Supplemental Application (Granules Pharmaceuticals Inc)

  FDA approved a supplemental application for gabapentin submitted by Granules Pharmaceuticals Inc.

• FDA approval · 2020-07-28
  FDA Approved: LEVETIRACETAM — Supplemental Application (Camber Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for an oral levetiracetam product from Camber Pharmaceuticals, Inc., under an ANDA.

• FDA approval · 2020-07-24
  FDA Approved: LEVETIRACETAM — Supplemental Application (Aryeh Pharma corp)

  FDA approved a supplemental application for levetiracetam from Aryeh Pharma Corp under ANDA 091485.